Device Classification Name |
pedicle screw spinal system, adolescent idiopathic scoliosis
|
510(k) Number |
K121630 |
Device Name |
RANGE SPINAL SYSTEM |
Applicant |
K2M, INC. |
751 MILLER DR., S.E., SUITE F1 |
Leesburg,
VA
20175
|
|
Applicant Contact |
NANCY GIEZEN |
Correspondent |
K2M, INC. |
751 MILLER DR., S.E., SUITE F1 |
Leesburg,
VA
20175
|
|
Correspondent Contact |
NANCY GIEZEN |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/04/2012 |
Decision Date | 09/11/2012 |
Decision |
SE - With Limitations
(SESU) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|